Phase II: To evaluate the efficacy of the dose/level regimen of RAD001 recommended from the phase I with trastuzumab and paclitaxel therapy. This will be based on the overall response rate. [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: January 23, 2007)

To establish the feasible dose levels/regimens based on end-of-cycle-1 dose limiting toxicity

Phase I : Assess ability to deliver trastuzumab and paclitaxel therapy based on the relative dose intensity of paclitaxel & on the discontinuation rate of trastuzumab, assess everolimus, trastuzumab & paclitaxel PK in a subset of patients [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: No ]

To evaluate progression free survival (PFS), overall survival(OS) and to describe the safety profile of the phase II part combination. [ Time Frame: every 8 - 9 weeks and for OS, every 3 months ] [ Designated as safety issue: Yes ]

To assess the ability to deliver the trastuzumab and paclitaxel therapy

To assess everolimus, trastuzumab and paclitaxel blood levels in this combination

To evaluate the overall tumor response

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Official Title ICMJE

A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer

Brief Summary

Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start

Patients who have previously received mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects